BS EN ISO 21649:2009 BS EN ISO 21649:2009 Needle-free injectors for medical use. Requirements and test methods
BS EN ISO 21649 is the British Standard applicable to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.
The dose chamber of the injection system is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber also may be a permanent internal chamber designed to last through the claimed life of the device.
BS EN ISO 21649 applies to needle-free injectors primarily intended to administer medicinal products to humans. Because of the anticipated variation in the designs of such a broad array of devices, this BS EN ISO 21649 is promulgated more as a “horizontal” rather than a “vertical” one. Thus, it will tend to specify the results of the design effort instead of the physical and construction requirements used as the basis for device design, so that innovation in achieving the intended purposes is not unnecessarily restricted.
Standards of this nature intentionally avoid addressing more than the most basic elements regarding the safety and performance of needle-free injector devices in humans. Any intended labelling of such devices indicating their use to deliver medicinal products into the body or into specified tissue compartments thereof (e.g., intramuscular, subcutaneous or intradermal), or for the administration of specific pharmaceutical drugs or vaccines, shall fall under the authority of national governments or supranational agencies regulating the manufacture and marketing of medical devices and pharmaceutical products.
Such standards are expected to be supplemented by additional requirements and may occasionally be superseded by such regulatory authorities. Despite certain advantages for intentional interchangeability for dose chambers designed for different needle-free injection systems, as well as the potential risks of inadvertent interchangeability, these standards avoid setting forth design specifications for the uniform size, shape and interface of such dose chambers. This issue is left for future initiatives to build upon the standards promulgated herein.
The sampling plans for inspection selected for BS EN ISO21669 are intended to verify the design, at a high confidence level, i.e., the manufacturer's ability to manufacture one “lot” of needle-free injectors, which conforms to the critical product attributes. The sampling plan does not replace the more general manufacturing quality systems, including lot release, which appear in standards on quality systems, e.g. the ISO 9000 series or ISO 13485.
Contents of BS EN ISO 21649 include:- Scope
- Normative references
- Terms and definitions
- Symbols and abbreviated terms
- General requirements
- Noise requirements
- Dose specification requirements
- Uncertainty of measurements and conformance with specifications
- Performance profile requirements
- Test requirements
- Test methods
- Test procedures
- Test conditions
- Test evaluations
- Test report
- Information supplied by the manufacturer
- Marking
- Instructions for use
- Two-sided tolerance limit factors (k)
- Examples of accuracy limit calculations and random settings
- Correspondence between ISO/IEC standards and EN standards
- Relationship between this International Standard and the Essential
- Requirements of EU Directive 93/42/EEC
- Bibliography
The following are not covered, drug delivery methods that:
- Involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices)
- Generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters)
- Deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops)
- Apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices)
- Infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.
BS EN ISO 21649 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
BS EN ISO 21649:2009 supersedes EN ISO 21649:2006 which has been withdrawn.
